Protocol summary
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Study aim
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Comparison of the effect of traditional and computerized emotional facial education training on children with autism on mother-child relationships and parental competence
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Design
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Clinical trial with two intervention groups and one control group with parallel, two-way blind groups, randomized
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Settings and conduct
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This study will be conducted in autism centers affiliated with Hamedan University of Medical Sciences in two blind directions, the person who completes the questionnaires and the person who will analyze the data will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Children 6-15 years old with moderate to severe autism who have the ability to work with the computer at an early age and whose mothers are able to participate in the child's education.
Exclusion criteria:Absence of children in three sessions or more during training
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Intervention groups
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The traditional intervention group includes children with autism who will use 40 images related to different situations to teach emotional facial recognition, and the child must choose the appropriate emotional state with the help of the researcher and the mother. When it recognizes one image correctly, it is encouraged and the next image is displayed. However, in case of a wrong answer, the researcher points out that "try again" and an indirect reference is given to the correct answer.
The computer intervention group includes children with autism who will be taught the Let's Face It educational software (6 stages of play) in such a way that each child is trained by the researcher together with the mother and plays all the stages of the software independently. At the end of all games, the child's score will be estimated.
The control group will receive routine training.
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Main outcome variables
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Mother-child relationship؛ Parental competence
General information
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Reason for update
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Complete the information in the sampling section
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190703044082N2
Registration date:
2020-06-06, 1399/03/17
Registration timing:
prospective
Last update:
2020-07-26, 1399/05/05
Update count:
1
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Registration date
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2020-06-06, 1399/03/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-11-21, 1399/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of traditional face computer training on children with autism on mother-child relationships and parental competence in autism centers
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Public title
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Comparison of the effect of traditional and computerized emotional facial education training on children with autism
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Based on the DSM-IV Manual of Psychiatric Disorders, according to a psychiatrist's assessment of a child and adolescent child with high and moderate performance autism
In the pediatric medical records, they received 22 scores from the instructor or 19 scores from the mother based on the Autism Scale questionnaire
Has the ability to understand and practice experimental exercises
Lack of mental retardation or other known physical, cognitive, evolutionary-disease
Lack of visual impairment
Their mothers are satisfied with the child's participation in the study
Their mothers are able to participate in the child's education and participate in the study
Ability to work with computers at elementary level
Exclusion criteria:
Absence of children in three sessions or more during training
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Age
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From 6 years old to 15 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Parallel block random allocation will be used to randomly allocate high and moderate performance autistic children to traditional, computerized and control groups. Write the names of the three groups on a piece of paper and randomize them and specify the order of sampling.For random allocation of samples in three traditional, computerized and control groups, 20 blocks of 6 blocks will be used as random block allocation. Thus, the letter A for the computer group, the letter B for the traditional group and the letter C for the control group will be considered.On the pieces of paper, WILL write the blocks and put them in the envelope and we will randomly remove the the pieces of paper. next according to the probable order of sampling will start.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The person who completes the questionnaires will be blinded by the allocation of individuals in the intervention groups.In addition, the person who analyzes the data will be blinded to the allocation of individuals to the groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-16, 1398/04/25
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Ethics committee reference number
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IR.UMSHA.REC.1399.215
Health conditions studied
1
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Description of health condition studied
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Autism
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ICD-10 code
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f84
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ICD-10 code description
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childhood autism
Primary outcomes
1
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Description
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Maternal-child relationships with autism 6-12 years in Ross questionnaire
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Timepoint
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1 day before training and 1 and 7 days after training
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Method of measurement
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Ross questionnaire
2
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Description
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Parental Competence in Parents of Autistic Children in (PCS)questionnaire
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Timepoint
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1 day before training and 1 and 7 days after training
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Method of measurement
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(PCS)questionnaire
3
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Description
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Emotional face identification in children with autism
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Timepoint
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1 day before training and 1 and 7 days after training
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Method of measurement
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Modified Benton Face Recognition Scale
Intervention groups
1
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Description
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Intervention group( traditional method) : In this method, the children will be trained by the researcher with the mother in 10 sessions of 30 to 60 minutes.It will be used To train 40 different images related to 4 positions of happiness, sadness, anger and fear (From each mode, 10 images) and The child should, with the help of the researcher and the mother, select the right emotional state appropriate to the target's face.All faces are a picture of a boy in size A5 and colorful.Images are displayed individually and from the front view to the child and without any explanation, the child is asked to select any image appropriate to the target's face. Every time they recognize a picture correctly, they will be encouraged by the mother and the researcher, and the next image will be shown. But in the event of a wrong answer, the researcher or the mother reminds you to "try again" and an indirect reference to the correct answer And if the wrong answer is repeated, direct reference is given to the correct answer And this process will be repeated until the participant gives the correct answer.In each session, four pictures (one image of each emotional state) are taught to the child. The mother is present with the researcher and learns how to train. Whenever a mother expresses her willingness to educate the child, the researcher assigns one or more of the images to her And supervises the child's education by the mother so that the training is done correctly. In this case, the researcher will express it if it is necessary to provide a point. At the end of each training session, if the mothers have ambiguity and questions about the trained images in each session, the researcher will respond to them.
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Category
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Rehabilitation
2
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Description
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Intervention group (computer method): To teach computer method, the participants will be trained by a researcher with the mother with LFI software in 30 to 60 minutes during 10 sessions.In this method, the researcher teaches Let's Face It educational software (6 game stages) for each of the participants independently, using a laptop device in each session. Each child will independently play all the steps of the software with the help and guidance of a researcher.This software consists of 8 links, the logo of each link is the face of an animal that enters the game by clicking on it. game links include: Lion, Stork, Zebra, Monkey, Rhinoceros, Crocodile, Elephant and Blue Horse, all of which will improve the understanding and recognition of emotions in all its dimensions.Each stage of the game has many advantages that are set to encourage the child to play more and more.At the end of all games, each participant's score will be added and the child's score will be estimated. At the end of each training session, if the mothers have any ambiguities or questions about the images taught in each session, the researcher will answer them.
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Category
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Rehabilitation
3
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Description
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Control group: The control group receives routine training
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable